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ClinicalTrials.gov Identifier: NCT00928187

Recruitment Status :
Completed

First Posted : June 25, 2009

Results First Posted : November 8, 2016

Last Update Posted : February 27, 2017

Sponsor:

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborators:

Gilead Sciences

Janssen Pharmaceutica

Information provided by (Responsible Party):

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Since the first line antiretroviral (ARV) treatment is now largely accessible in the Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns and second line treatment evaluation are still to be consolidated in settings where viral load monitoring is not available and non-B HIV subtype is predominant.

This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor associated with a ritonavir boosted protease inhibitor (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir); the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a better tolerance and its single daily administration may facilitate treatment adherence.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient over the age of 18 years at pre-inclusion and monitored under outpatient conditions

Patient agrees not to take any concomitant medication during the trial without informing the investigator

Informed consent signed no later than D-15

For women in childbearing age: negative pregnancy test at inclusion, with no plan of pregnancy in the coming 12 months and agreeing to use mechanical contraception (with or without hormonal contraception) during the study

Exclusion Criteria:

Infection with HIV-2 or HIV-1 groups O or N or HIV1+2

Deficiency of the patient, making it difficult, if not impossible, for him/her to take part in the trial or understand the information provided to him/her

Participation in any other clinical trial

Presence of an uncontrolled, ongoing opportunistic infection or of any severe or progressive disease

First-line treatment with a protease inhibitor, abacavir, tenofovir or ddI

Ongoing treatment with rifampicin

Severe hepatic insufficiency (TP < 50%)

ALAT > 3 x ULN

Creatinine clearance calculated by Cockcroft formula < 50 ml/min

Hb ≤ 8 g/dl

Platelets < 50,000 cells/mm3

Neutrophiles < 500 cells/ mm3

Use of drugs prohibited in the context of this trial (drugs contraindicated by the SCP of the trial drugs) - in the event of tuberculosis or malaria during the trial, a list of authorized medicines and, if necessary, a dose adjustment of the antiretroviral medication will be provided